Novartis announced disappointing results from its Phase III GCAptAIN study evaluating Cosentyx (secukinumab) in adults with newly diagnosed or relapsing giant cell arteritis (GCA), with the trial failing to meet its primary endpoint of sustained remission at Week 52.
Study Design and Results
The GCAptAIN trial (NCT04930094) was a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted across 27 countries. The study evaluated Cosentyx in combination with a 26-week steroid taper compared to placebo plus a 52-week steroid taper. Patients were randomized into three treatment arms: Cosentyx 300 mg, Cosentyx 150 mg, or placebo, all in combination with a glucocorticoid taper regimen.
The primary endpoint assessed whether secukinumab 300 mg subcutaneous plus a 26-week glucocorticoid taper was superior to placebo plus a 52-week glucocorticoid taper in achieving sustained remission at Week 52. Cosentyx did not demonstrate a statistically significant improvement in sustained remission at Week 52 compared to placebo.
While the secondary outcomes did not show statistical superiority, Cosentyx showed numerically better outcomes compared to placebo for cumulative steroid dose and steroid-related toxicity. The first secondary endpoint was the cumulative glucocorticoid dose through Week 52.
Safety Profile Maintained
Safety in GCA patients was consistent with the known safety profile of Cosentyx, which is supported by robust evidence and 10 years of real-world data across its approved indications. Since its launch in 2015, Cosentyx has been used to treat more than 1.8 million patients worldwide and is now approved in over 100 countries.
Company Response
"While the Phase III results of GCAptAIN did not replicate the positive outcomes observed in the Phase II trial, we remain committed to continuing to drive scientific progress and deepening the understanding of immune-mediated diseases," said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. "We are grateful to the patients, investigators, and teams who made this study possible and will continue focusing on addressing areas of unmet medical need."
Novartis will complete a full evaluation of the GCAptAIN data and share the results at a later date.
About Giant Cell Arteritis
Giant cell arteritis is the most common form of systemic vasculitis, primarily affecting people over 50 years of age. Because of its potential to cause irreversible vision loss and life-threatening aortic aneurysms, GCA is considered a medical emergency requiring prompt recognition and treatment. Beyond its physical complications, GCA significantly impairs quality of life, contributing to fatigue, cognitive difficulties, and reduced independence.
About Cosentyx
Cosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It is approved for use in adults with psoriatic arthritis, moderate to severe plaque psoriasis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa, as well as in pediatric patients with psoriasis, enthesitis-related arthritis, and juvenile psoriatic arthritis.
